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6 Cards in this Set
- Front
- Back
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Study Initiation The _________ of a newly approved/activated study requests that the study team at the lead site organizes a meeting to review the specifics of the ______ in preparation to enroll the first subject i.e. the science, design, procedures, and ______ completion. Attendees include? |
The sponsor/CRO of a newly approved/activated study requests that the study team at the lead site organizes a meeting to review the specifics of the protocol in preparation to enroll the first subject i.e. the science, design, procedures, and case report form (CRF) completion. Attendees include: the Overall Principal Investigator, Program Manager, Research Pharmacist, assigned Study Coordinator, and Research Nurse. |
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Study Initiation Trial Objectives and Purpose Trial Design - primary and secondary _______ - description of the _______ of trial to be conducted (e.g. double-blind, placebo-controlled, parallel design) and a schematic _______ of trial design, procedures and stages. - A description of the measures taken to minimize/avoid _______ - trial _______ and the _______ and _______ regimen of the investigational product(s). |
Trial Objectives and Purpose Trial Design - primary and secondary objectives/endpoints - description of the type/design of trial to be conducted (e.g. double-blind, placebo-controlled, parallel design) and a schematic diagram of trial design, procedures and stages. - A description of the measures taken to minimize/avoid bias - trial treatment(s) and the dosage and dosage regimen of the investigational product(s) |
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Study Initiation - The expected _______ of subject participation, and a description of the _______ and _______ of all trial periods, including follow-up, if any. - A description of the “_______ rules” or “_______ criteria” for individual subjects, parts of trial and entire trial. - _______ procedures for the investigational product(s), including the placebo(s) and comparator(s), if any. - Maintenance of trial treatment _______ codes and procedures for _______ codes. - The identification of any data to be recorded directly on the _______ (i.e. no prior written or electronic record of data), and to be considered to be source data. |
- The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up, if any. - A description of the “stopping rules” or “discontinuation criteria” for individual subjects, parts of trial and entire trial. - Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s), if any. - Maintenance of trial treatment randomization codes and procedures for breaking codes. - The identification of any data to be recorded directly on the CRFs (i.e. no prior written or electronic record of data), and to be considered to be source data. |
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Study Initiation Other important topics: - Accrual _______ and protocol _______ - _______ responsibilities and _______ analysis - Informed consent _______ - Protocol-specific _______ - _______ provided - Supplies and material _______ - Laboratory and sample _______ |
- Accrual target and protocol timeline - Financial responsibilities and coverage analysis - Informed consent language - Protocol-specific training - Equipment provided - Supplies and material procurement - Laboratory and sample management |
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Study Procedures Treatment of Subjects: - The treatment(s) to be _______, including the name(s) of all the _______(s), the _______(s), the dosing _______(s), the _______(s) of administration, and the treatment _______(s), including the _______ period(s) for subjects for each investigational product treatment/trial treatment _______ of the trial. - _______(s)/_______(s) permitted (including _______ medication) and not permitted before and/or during the trial. - Procedures for monitoring subject _______. |
- The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s) for subjects for each investigational product treatment/trial treatment group/arm of the trial. - Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial. - Procedures for monitoring subject compliance. |
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Study Assessments Assessment of Study Efficacy - Specification of _______ parameters - Methods and timing of _______, _______ and _______ of efficacy parameters Assessment of Safety - Specification of _______ parameters Methods and timing of _______, _______ and _______ of safety parameters Procedures for eliciting _______ and for recording and reporting _______ events and intercurrent _______ _______ and _______ of the follow up of subjects after adverse events |
Assessment of Study Efficacy - Specification of efficacy parameters - Methods and timing of assessing, recording and analysis of efficacy parameters Assessment of Safety - Specification of safety parameters Methods and timing of assessing, recording and analysis of safety parameters Procedures for eliciting reports and for recording and reporting adverse events and intercurrent illnesses |
